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The Italian Competition Authority fines a pharmaceutical company for charging excessive prices for an orphan drug (Leadiant)

The Italian Competition Authority (ICA) has recently closed an Article 102 TFEU enquiry against a pharmaceutical company in the Leadiant case with an infringement decision [1]. The ICA found that Leadiant, had abused its dominant position by charging highly disproportionate prices for a drug bearing the orphan designation in breach of Article 102 TFEU. Facts of the case Chenodeoxycholic acid (CDCA) is an active ingredient that is used for the production of drugs for the treatment of a very rare disease, cerebrotendineous xanthomatosis (CTX). Originally, the Azienda Ospedaliera Universitaria Senese (AOUS) managed to run a galenic production of a CDCA-based drug to meet its own needs and those of other hospitals. AOUS obtained the CDCA from PCA until these supplies ceased. Then it

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Michele Giannino, The Italian Competition Authority fines a pharmaceutical company for charging excessive prices for an orphan drug (Leadiant), 17 May 2022, e-Competitions Preview, Art. N° 108768

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